MalariaNCT01454752
Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
A study testing Intermittent parasite clearance in people with Malaria and Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Senegal.
Trial summary
Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria infection, clinical illness and death. By the time they reach school, many children have already acquired some clinical immunity and the ability to limit parasite growth, and thus most… Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- What is being tested?
- Intermittent parasite clearance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 860 participants
- Where
- 1 siteSenegal
- Study dates
- Nov 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- enrolled in participating elementary schooled
- provision of parental consent
Who cannot join
- lack of consent
- chronic conditions which limit regular school attendance
- clinical malaria on the day of scheduled treatment (as defined as febrile, with a positive result in a rapid diagnostic test for malaria).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Parasite Clearance (IPC) in Schools: a Randomised Double-blind Placebo-controlled Trial of the Impact of IPC on Malaria, Anaemia and Cognition Amongst School Children in Kedougou, Senegal
Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria infection, clinical illness and death. By the time they reach school, many children have already acquired some clinical immunity and the ability to limit parasite growth, and thus most infections are asymptomatic and will go undetected and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage may bring education, as well as health, benefits.
Intermittent parasite clearance (IPC) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes, and may usefully supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a policy of universal coverage of nets.
This study seeks to establish whether intermittent parasite clearance undertaken once a year at the end of the malaria transmission season can reduce malaria parasite carriage and anaemia amongst school-going children already using insecticide-treated nets, and its consequent impact on school attendance and performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes in areas of seasonal malaria transmission.
- Being tested
- Intermittent parasite clearance, Placebo
- Keywords
- malaria, anaemia, cognition, intermittent preventive treatment, children, schools, insecticide-treated nets
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent parasite clearanceDrug
Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days
PlaceboOther
Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days
| Study group | Role | What they receive |
|---|---|---|
| Intermittent parasite clearance | Active comparator | Children sleeping under a long-lasting insecticidal net (LLIN) receive an additional intermittent preventive treatment for clearance of asymptomatic malaria infection given once a year at the end of the malaria transmission season Receives: Drug: Intermittent parasite clearance |
| Control | Placebo comparator | Children sleeping under a long-lasting insecticidal net (LLIN) receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malaria parasitaemia
Measured: 8 weeks after treatment (February 2012)
Prevalence of anaemia (Haemoglobin<11 g/dL)
Measured: 8 weeks after treatment (February 2012)
Secondary outcomes (1)
Cognitive performance in tests of sustained attention
Measured: 8 weeks after treatment (February 2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Division Controle Medicale Scolaire, Ministry of Education, Senegal, Ministry of Health, Senegal, Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal, Cheikh Anta Diop University, Senegal, Institut de Recherche pour le Developpement, Senegal, Harvard University
- Responsible party
- Sponsor
- Investigators
- Sian E Clarke, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454752
- Sponsor's protocol ID
- WT-Clarke-Sen2011
- Status last verified
- Apr 2012
- First submitted
- 12 Oct 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Parasite Clearance (IPC) in Schools: a Randomised Double-blind Placebo-controlled Trial of the Impact of IPC on Malaria, Anaemia and Cognition Amongst School Children in Kedougou, Senegal
- ClinicalTrials.gov ID
- NCT01454752
- Acronym / sponsor ID
- WT-Clarke-Sen2011
- Keywords
- malaria, anaemia, cognition, intermittent preventive treatment, children, schools, insecticide-treated nets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Division Controle Medicale Scolaire, Ministry of Education, Senegal, Ministry of Health, Senegal, Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal, Cheikh Anta Diop University, Senegal, Institut de Recherche pour le Developpement, Senegal, Harvard University
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria infection, clinical illness and death. By the time they reach school, many children have already acquired some clinical immunity and the ability to limit parasite growth, and thus most infections are asymptomatic and will go undetected and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage may bring education, as well as health, benefits.
Intermittent parasite clearance (IPC) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes, and may usefully supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a policy of universal coverage of nets.
This study seeks to establish whether intermittent parasite clearance undertaken once a year at the end of the malaria transmission season can reduce malaria parasite carriage and anaemia amongst school-going children already using insecticide-treated nets, and its consequent impact on school attendance and performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes in areas of seasonal malaria transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent parasite clearance | Active comparator | Drug: Intermittent parasite clearanceChildren sleeping under a long-lasting insecticidal net (LLIN) receive an additional intermittent preventive treatment for clearance of asymptomatic malaria infection given once a year at the end of the malaria transmission season |
| Control | Placebo comparator | Other: PlaceboChildren sleeping under a long-lasting insecticidal net (LLIN) receive placebo |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- enrolled in participating elementary schooled
- provision of parental consent
Key exclusion criteria (3 listed)
- lack of consent
- chronic conditions which limit regular school attendance
- clinical malaria on the day of scheduled treatment (as defined as febrile, with a positive result in a rapid diagnostic test for malaria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent parasite clearanceSulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days | Drug | Intermittent parasite clearance |
| PlaceboPlacebo tablets, similar in appearance and taste to active treatment, given daily over 3 days | Other | Control |
Primary outcome
Prevalence of malaria parasitaemia
Time frame: 8 weeks after treatment (February 2012)
Prevalence of anaemia (Haemoglobin<11 g/dL)
Time frame: 8 weeks after treatment (February 2012)
1 secondary outcome
Cognitive performance in tests of sustained attention
Time frame: 8 weeks after treatment (February 2012)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sian E Clarke, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent parasite clearance in people with Malaria and Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malaria parasitaemia (time frame: 8 weeks after treatment (February 2012)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.